Overview
Cefixime, an antibiotic, is a third-generation cephalosporin like ceftriaxone and cefotaxime. Cefixime is highly stable in the presence of beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases, may be susceptible to cefixime. The antibacterial effect of cefixime results from inhibition of mucopeptide synthesis in the bacterial cell wall.
Indication
For use in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: (1) uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis, (2) otitis media caused by Haemophilus influenzae (beta-lactamase positive and negative strains), Moraxella catarrhalis (most of which are beta-lactamase positive), and S. pyogenes, (3) pharyngitis and tonsillitis caused by S. pyogenes, (4) acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae (beta-lactamase positive and negative strains), and (5) uncomplicated gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains).
Associated Conditions
- Acute Exacerbation of Chronic Bronchitis caused by Streptococcus Pneumoniae
- Acute Exacerbations of Chronic Bronchitis caused by Haemophilus Influenzae
- Bacterial Sinusitis
- Community Acquired Pneumonia (CAP)
- Gonorrhea of anus
- Lyme Disease
- Salmonella Infections
- Shigella Infection
- Streptococcal Pharyngitis
- Tonsillitis streptococcal
- Uncomplicated Urinary Tract Infections
- Bacterial otitis media
- Bacterial rhinosinusitis
- Disease caused by Salmonella typhi
- Uncomplicated Gonorrhea
Research Report
Cefixime (DB00671): A Comprehensive Pharmacological and Clinical Monograph
1.0 Executive Summary
1.1 Overview of Cefixime
Cefixime is a semisynthetic, orally active, third-generation cephalosporin antibiotic. Identified by DrugBank Accession Number DB00671 and CAS Number 79350-37-1, it is classified as a small molecule drug.[1] Cefixime exerts a bactericidal effect by inhibiting the synthesis of the bacterial cell wall, a mechanism characteristic of β-lactam antibiotics.[1] Its chemical structure confers stability against many common β-lactamase enzymes, allowing it to maintain efficacy against pathogens that are resistant to penicillins and earlier-generation cephalosporins.[2]
1.2 Key Pharmacological Characteristics
The pharmacokinetic profile of cefixime is notable for its partial oral absorption (30-50%), which is significantly influenced by the pharmaceutical formulation; the oral suspension achieves higher peak concentrations than solid dosage forms.[5] Food delays the time to maximum concentration but does not substantially alter the overall absorption of tablets and suspension.[4] The drug is approximately 65-70% bound to plasma proteins and is distributed to various tissues, including the respiratory and urinary tracts.[5] Critically, cefixime is not metabolized in vivo and is primarily excreted unchanged by the kidneys, with a smaller fraction eliminated through the bile.[4] This reliance on renal clearance mandates dosage adjustments in patients with renal impairment. The elimination half-life averages 3 to 4 hours, which supports convenient once or twice-daily dosing regimens.[7]
1.3 Summary of Clinical Applications and Limitations
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/04/02 | Phase 4 | Terminated | Bulovka Hospital | ||
2023/10/19 | Phase 4 | Completed | Bulovka Hospital | ||
2022/03/24 | Phase 2 | Recruiting | |||
2022/01/31 | Phase 2 | Completed | Haiphong University of Medicine and Pharmacy | ||
2021/08/30 | Not Applicable | UNKNOWN | |||
2021/07/29 | Not Applicable | Completed | |||
2021/07/12 | Phase 3 | Recruiting | |||
2020/04/16 | Phase 4 | Recruiting | |||
2019/05/31 | Phase 3 | UNKNOWN | Post Graduate Institute of Medical Education and Research, Chandigarh | ||
2019/02/15 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Lupin Pharmaceuticals, Inc. | 27437-206 | ORAL | 200 mg in 5 mL | 12/15/2023 | |
Lupin Pharmaceuticals, Inc. | 27437-201 | ORAL | 400 mg in 1 1 | 12/15/2023 | |
Lupin Pharmaceuticals, Inc. | 27437-208 | ORAL | 400 mg in 1 1 | 12/15/2023 | |
Lupin Pharmaceuticals, Inc. | 68180-416 | ORAL | 400 mg in 1 1 | 7/11/2025 | |
Aurobindo Pharma Limited | 65862-752 | ORAL | 200 mg in 5 mL | 2/14/2024 | |
Lupin Pharmaceuticals, Inc. | 68180-423 | ORAL | 400 mg in 1 1 | 7/11/2025 | |
Lupin Pharmaceuticals, Inc. | 68180-405 | ORAL | 100 mg in 5 mL | 7/11/2025 | |
Aurobindo Pharma Limited | 65862-751 | ORAL | 100 mg in 5 mL | 2/14/2024 | |
Ascend Laboratories, LLC | 67877-584 | ORAL | 400 mg in 1 1 | 11/30/2021 | |
Lupin Pharmaceuticals, Inc. | 27437-205 | ORAL | 200 mg in 1 1 | 12/15/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
SUPRAX | odan laboratories ltd | 00868981 | Tablet - Oral | 400 MG | 12/31/1990 |
SUPRAX | aventis pharma inc | 02195984 | Tablet - Oral | 400 MG | 12/31/1990 |
SUPRAX | odan laboratories ltd | 00868965 | Powder For Suspension - Oral | 100 MG / 5 ML | 12/31/1990 |
SUPRAX | sanofi-aventis canada inc | 00868973 | Tablet - Oral | 200 MG | 12/31/1990 |
AURO-CEFIXIME | auro pharma inc | 02432773 | Tablet - Oral | 400 MG | 10/24/2014 |
SUPRAX | aventis pharma inc | 02195992 | Powder For Solution - Oral | 100 MG / 5 ML | 12/31/1990 |
SUPRAX - TAB 200MG | rhone-poulenc rorer canada inc. | 02195976 | Tablet - Oral | 200 MG / TAB | 12/31/1990 |
AURO-CEFIXIME | auro pharma inc | 02468689 | Powder For Suspension - Oral | 100 MG / 5 ML | 1/8/2018 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
CEFIXIMA REIWA HEALTHCARE 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Reiwa Healthcare S.L. | 88325 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
DENVAR 100 MG/5 ML GRANULADO PARA SUSPENSIÓN ORAL | Merck S.L. | 59733 | GRANULADO PARA SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
CEFIXIMA SANDOZ 400 MG CAPSULAS DURAS EFG | Sandoz Farmaceutica S.A. | 65856 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
DENVAR 400 mg CAPSULAS | Merck S.L. | 60469 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized |
DENVAR 200 mg CAPSULAS | Merck S.L. | 58819 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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